BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 2038661 · Received March 25, 2011

    Report

    Report Number
    1818910-2011-04986
    Event Type
    Injury
    Date Received
    March 25, 2011
    Report Date
    February 23, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT HAS SUFFERED, AND CONTINUES TO SUFFER, INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, EMOTIONAL DISTRESS, PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING; PAST, PRESENT AND FUTURE MEDICAL, HOSPITAL, MONITORING, REHABILITATIVE AND PHARMACEUTICAL EXPENSES, AND LOST WAGES, EXCESSIVE EXPOSURE TO METAL CONTAMINATION OF HIS BLOOD AND BODY BY COBALT AND CHROMIUM AND OTHER SUBSTANCES TOXIC TO THE PATIENT, LOSS OF EXPECTANCY OF LIFE, EXPOSURE TO HIGHER THAN NORMAL RATES OF CANCER, ORGAN FAILURE, AND OTHER POTENTIAL FUTURE HEALTH COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP TOTAL HIP PROSTHESIS KWA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention